To usher in the new paradigm of personalized medicine we will need to travel a perilous path. Much like the route through the Himalayas it has punished the naive and self-reliant. That is why I have dedicated my life to being a Gene Sherpa. What is a gene sherpa? The Sherpa speaks the language of the trail, he/she knows short cuts and dangerous paths to avoid. This blog is for those wishing to take the journey and those wishing to become Gene Sherpas.

"AG: The law requires us to clear devices or approve devices BEFORE they go into the marketplace when they make medical claims"

This to me is crystal clear. Make a medical claim. Get regulated.

Which is interesting. Because I would say some of what DTCG did was, infer medical claims without making outright claims- silly games . I happen to think that is a shitty way to sell something. But heck it is a way to create a discussion rather than instant regs.....

"AG: The question with 23andMe has been whether their claims were medical or not. The original claims they were making were very much on the edge."

"AG: We actually told them that WE(FDA) thought they were medical claims, but it was at least possible you could argue that they were not"

Do you get it? The judge thought they were medical claims, but let the company proceed. Giving it just enough rope to hang itself.......

15 comments:

If I sell something that promises to diagnose, treat or cure then I am selling a medical device according to FDA

If I claim to do something to prevent human suffering or advance human health I could be doing or writing about scientific research so not a medical device or claim.

I can go to WebMD and read health information about me or at least about someone with some similar characteristics. E.g. I can read about my disease risk based on things I do, my blood biomarkers and height & weight etc. If I go to 23andMe I can read health related information about me, or rather about populations with similar genotypes to me. What's the difference, especially as the FDA have declared that they have no problem with me obtaining my raw genotype data - I go into this a bit more in my dissection of the FDA/DNA Dilemma article here: http://bit.ly/aAoFRK

In case readers here are unaware of the context of this threat: you've posed the same question in no fewer than seven separate comments on Genomes Unzipped, and it's no less trivial now that it was when you first asked it. Forgive us if we're getting a little sick of it.

This is not the crucial question here; indeed, it's nothing more than semantics. We shouldn't be regulating on the basis of whether or not a test fulfils some arbitrary definition of medicine (put forward, I add, by someone with a financial stake in maintaining the status quo). Instead, we should regulate on the basis of more pragmatic questions:

1. Are the results of this test conveyed accurately to consumers?2. Are false claims made by the providers of the test for marketing purposes?3. Are customers provided with sufficient information to assess the validity and utility of the test results?4. Is there evidence that this test, as currently provided, will do harm to recipients?5. Is there evidence that this test, as currently provided, will benefit recipients?

These are the questions that matter, Steve - and your focus on an irrelevant semantic issue is nothing more than a distraction from the interesting discussion that needs to be had: how can we best ensure that testing companies provide accurate results, refrain from false advertising, provide transparent, accessible information about test validity and utility? How do we gather the information required to assess the benefits and harms experienced by test recipients? And how do we achieve these goals without stifling innovation or inhibiting the public right to self-education and exploration of their own genome?

@Daniel,Your "interesting" questions, which I think are academic actually CANNOT proceed until we define whether a test should even be regulated and be evaluated by these so called criteria you propose.

Am I incorrect? Or do you make the jump that ALL DTCG tests are included in the regs?

The decision as to whether additional regulation is required over and above existing standards (CLIA, FTC etc.) should be made on the basis of question 4: Is there evidence that this test, as currently provided, will do harm to recipients? If the evidence for potential harm is weak or non-existent (as it is currently), there's no reason for additional regulation.

"The decision as to whether additional regulation is required over and above existing standards (CLIA, FTC etc.) should be made on the basis of question 4: Is there evidence that this test, as currently provided, will do harm to recipients? If the evidence for potential harm is weak or non-existent (as it is currently), there's no reason for additional regulation."

By saying this, what you have then set up is a "sliding scale of harm"

See here

http://www.youtube.com/watch?v=a11t5NXaOQI

This is the sort of sham that allows Guys like Andrew Weil to pimp his vitamins and "holistic centers"

I think the decision to regulate is simple.

If you make a medical claim, you get a medical regulation.

AG is on point with that one. It is US law.

As for me standing to profit.

Daniel I have so much business from seeing general medicine....

DTCG consults are a true pain, they take forever. And insurance pays you little to nothing, And in this poor economic environment no one, I mean no one self pays. Not even on Park Avenue NYC.

So, rent seeking is a silly term for this. Because with each consult I actually lose money from draining productivity from somewhere else.

I get paid just as much to see hypertension as I do to do a whole DTCG consult.

This is not about markets here, it is about what is right and saying what you are.

I am not a big fan of trying to blur the lines to gain some economic advantage.

When you give me shit for semantics I laugh. Why?

That is the game being played and had been since 2007 in Mountain View, Redwood City, etc.

Listen Daniel, I respect you. But it is clear you are being blind here.

"The decision as to whether additional regulation is required over and above existing standards (CLIA, FTC etc.) should be made on the basis of question 4: Is there evidence that this test, as currently provided, will do harm to recipients? If the evidence for potential harm is weak or non-existent (as it is currently), there's no reason for additional regulation."

By saying this, what you have then set up is a "sliding scale of harm"

See here

http://www.youtube.com/watch?v=a11t5NXaOQI

This is the sort of sham that allows Guys like Andrew Weil to pimp his vitamins and "holistic centers"

I think the decision to regulate is simple.

If you make a medical claim, you get a medical regulation.

AG is on point with that one. It is US law.

As for me standing to profit.

Daniel I have so much business from seeing general medicine....

DTCG consults are a true pain, they take forever. And insurance pays you little to nothing, And in this poor economic environment no one, I mean no one self pays. Not even on Park Avenue NYC.

So, rent seeking is a silly term for this. Because with each consult I actually lose money from draining productivity from somewhere else.

I get paid just as much to see hypertension as I do to do a whole DTCG consult.

This is not about markets here, it is about what is right and saying what you are.

I am not a big fan of trying to blur the lines to gain some economic advantage.

When you give me shit for semantics I laugh. Why?

That is the game being played and had been since 2007 in Mountain View, Redwood City, etc.

Listen Daniel, I respect you. But it is clear you are being blind here.

"The decision as to whether additional regulation is required over and above existing standards (CLIA, FTC etc.) should be made on the basis of question 4: Is there evidence that this test, as currently provided, will do harm to recipients? If the evidence for potential harm is weak or non-existent (as it is currently), there's no reason for additional regulation."

By saying this, what you have then set up is a "sliding scale of harm"

See here

http://www.youtube.com/watch?v=a11t5NXaOQI

This is the sort of sham that allows Guys like Andrew Weil to pimp his vitamins and "holistic centers"

I think the decision to regulate is simple.

If you make a medical claim, you get a medical regulation.

AG is on point with that one. It is US law.

As for me standing to profit.

Daniel I have so much business from seeing general medicine....

DTCG consults are a true pain, they take forever. And insurance pays you little to nothing, And in this poor economic environment no one, I mean no one self pays. Not even on Park Avenue NYC.

So, rent seeking is a silly term for this. Because with each consult I actually lose money from draining productivity from somewhere else.

I get paid just as much to see hypertension as I do to do a whole DTCG consult.

This is not about markets here, it is about what is right and saying what you are.

I am not a big fan of trying to blur the lines to gain some economic advantage.

When you give me shit for semantics I laugh. Why?

That is the game being played and had been since 2007 in Mountain View, Redwood City, etc.

Listen Daniel, I respect you. But it is clear you are being blind here.

"The decision as to whether additional regulation is required over and above existing standards (CLIA, FTC etc.) should be made on the basis of question 4: Is there evidence that this test, as currently provided, will do harm to recipients? If the evidence for potential harm is weak or non-existent (as it is currently), there's no reason for additional regulation."

By saying this, what you have then set up is a "sliding scale of harm"

See here

http://www.youtube.com/watch?v=a11t5NXaOQI

This is the sort of sham that allows Guys like Andrew Weil to pimp his vitamins and "holistic centers"

I think the decision to regulate is simple.

If you make a medical claim, you get a medical regulation.

AG is on point with that one. It is US law.

As for me standing to profit.

Daniel I have so much business from seeing general medicine....

DTCG consults are a true pain, they take forever. And insurance pays you little to nothing, And in this poor economic environment no one, I mean no one self pays. Not even on Park Avenue NYC.

So, rent seeking is a silly term for this. Because with each consult I actually lose money from draining productivity from somewhere else.

I get paid just as much to see hypertension as I do to do a whole DTCG consult.

This is not about markets here, it is about what is right and saying what you are.

I am not a big fan of trying to blur the lines to gain some economic advantage.

When you give me shit for semantics I laugh. Why?

That is the game being played and had been since 2007 in Mountain View, Redwood City, etc.

Listen Daniel, I respect you. But it is clear you are being blind here.

"The decision as to whether additional regulation is required over and above existing standards (CLIA, FTC etc.) should be made on the basis of question 4: Is there evidence that this test, as currently provided, will do harm to recipients? If the evidence for potential harm is weak or non-existent (as it is currently), there's no reason for additional regulation."

By saying this, what you have then set up is a "sliding scale of harm"

See here

http://www.youtube.com/watch?v=a11t5NXaOQI

This is the sort of sham that allows Guys like Andrew Weil to pimp his vitamins and "holistic centers"

I think the decision to regulate is simple.

If you make a medical claim, you get a medical regulation.

AG is on point with that one. It is US law.

As for me standing to profit.

Daniel I have so much business from seeing general medicine....

DTCG consults are a true pain, they take forever. And insurance pays you little to nothing, And in this poor economic environment no one, I mean no one self pays. Not even on Park Avenue NYC.

So, rent seeking is a silly term for this. Because with each consult I actually lose money from draining productivity from somewhere else.

I get paid just as much to see hypertension as I do to do a whole DTCG consult.

This is not about markets here, it is about what is right and saying what you are.

I am not a big fan of trying to blur the lines to gain some economic advantage.

When you give me shit for semantics I laugh. Why?

That is the game being played and had been since 2007 in Mountain View, Redwood City, etc.

Listen Daniel, I respect you. But it is clear you are being blind here.

"The decision as to whether additional regulation is required over and above existing standards (CLIA, FTC etc.) should be made on the basis of question 4: Is there evidence that this test, as currently provided, will do harm to recipients? If the evidence for potential harm is weak or non-existent (as it is currently), there's no reason for additional regulation."

By saying this, what you have then set up is a "sliding scale of harm"

See here

http://www.youtube.com/watch?v=a11t5NXaOQI

This is the sort of sham that allows Guys like Andrew Weil to pimp his vitamins and "holistic centers"

I think the decision to regulate is simple.

If you make a medical claim, you get a medical regulation.

AG is on point with that one. It is US law.

As for me standing to profit.

Daniel I have so much business from seeing general medicine....

DTCG consults are a true pain, they take forever. And insurance pays you little to nothing, And in this poor economic environment no one, I mean no one self pays. Not even on Park Avenue NYC.

So, rent seeking is a silly term for this. Because with each consult I actually lose money from draining productivity from somewhere else.

I get paid just as much to see hypertension as I do to do a whole DTCG consult.

This is not about markets here, it is about what is right and saying what you are.

I am not a big fan of trying to blur the lines to gain some economic advantage.

When you give me shit for semantics I laugh. Why?

That is the game being played and had been since 2007 in Mountain View, Redwood City, etc.

Listen Daniel, I respect you. But it is clear you are being blind here.

Steve - looks like you have Blogger problems as well - multiple comments from you, I know you keep saying the same things over and over but I think this time it's unintended?

Anyway - sliding scale of harm? as you know, I have put up an argument about why I think it's safe - it's a long argument but all that is needed to refute it is a single sentence containing any good reason (specific, not "it's medicine", nor anecdotal etc) why it is wrong - http://bit.ly/agjs9v

None of what you have said so far, here or on any other of your comments or posts that I have seen contain one. You can disagree with what I say, and with Daniel's opinion above - but that make's no difference, that's just an opinion, it's not a reason.

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